Guaifenesin

Manufacturer: REMEDYREPACK INC.
Effective date: 2017-08-01
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:52:06

Label at a glance#

ProductGuaifenesin

Active ingredientGUAIFENESIN

Label structure9 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over 1 to 2 tablets every 4 hours children 6 to under 12 years of age ½ to 1 tablet every 4 hours children under 6 years of age consult a physician

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) use by expiration date on package

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

Active ingredient (in each immediate-release tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not exceed 6 doses in 24 hours
take with a full glass of water

adults and children 12 years of age and over	1 to 2 tablets every 4 hours
children 6 to under 12 years of age	½ to 1 tablet every 4 hours
children under 6 years of age	consult a physician

Other information

STORAGE AND HANDLING SECTION

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Guaifenesin

GENERIC: Guaifenesin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-511-02

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 44;588

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

GUAIFENESIN 200mg in 1

INACTIVE INGREDIENT(S):

FD&C RED NO. 40
MAGNESIUM STEARATE
STEARIC ACID
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MALTODEXTRIN
SILICON DIOXIDE

Remedy_Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197741	guaiFENesin 200 MG Oral Tablet	PSN	2
197741	guaifenesin 200 MG Oral Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49349-511-02	2020-01-31	C162847	48780-1	9d75b9cf-dc4f-f424-e053-dadaa90a57ce	Major 44-588

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49349-511-02	Guaifenesin	30 in 1 BLISTER PACK	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49349-511	GUAIFENESIN TABLET [REMEDYREPACK INC.]	2	Legacy NDC, 1 package rows	20170802_15c87250-7c30-4565-b451-b87c6754a371.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5154-60	EA - Each	0904-5154	0d39630a-f133-4d2c-bf29-7ec9c4ac5ca9	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Guaifenesin
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STEARIC ACID
FD&C RED NO. 40
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49349-511	49349-511-02
0904-5154

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin	GUAIFENESIN	Major Pharmaceuticals	aa662428-e61f-4e22-af4d-8cf63df68c99	2026-06-08	Warnings	Exact identifier ndc (product): 0904-5154
55b8913b-47a4-453b-e054-00144ff88e88			15c87250-7c30-4565-b451-b87c6754a371	2017-08-01	Warnings	Exact identifier spl id: 55b8913b-47a4-453b-e054-00144ff88e88 spl set id: 15c87250-7c30-4565-b451-b87c6754a371

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.